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Protection of Human Subjects

All research conducted at the Department of Energy, supported with DOE funds, or performed by DOE employees, including classified and proprietary, must comply with federal regulations and DOE Orders to protect human subjects. Requirements to protect human subjects apply to a much broader range of research than many investigators and program managers realize. All DOE employees, contractors and grantees must be mindful of the importance of protecting the rights and welfare of human subject research volunteers. If your research uses human specimens or records, you must comply with federal regulations and U.S. Department of Energy (DOE) orders to protect human subjects.

In a world of rapidly advancing medical technology, revolutionary genetics research, and ever-increasing threats to personal privacy, the protection of human subjects in research is paramount.

The goal of the Human Subjects Research program is to ensure that the rights and welfare of human research subjects are protected while advances in biomedical, environmental, nuclear and other research continue to lead to discoveries that benefit humanity.

The Institutional Review Board (IRB) at the INL must review and approve your research if it involves the use of human subjects. This process is designed to ensure that the research protects the rights and welfare of human subjects by minimizing risk and maximizing benefit, selecting subjects equitably, obtaining informed consent, and ensuring privacy and confidentiality.

IRB approval must precede initiation of any actual work involving human subjects. The IRB must re-review and approve the ongoing project at least annually. The IRB must review and approve any proposed changes in the procedures of an approved project. The IRB must be notified if human subjects are harmed, or if your research is not being conducted in accord with IRB requirements. Required IRB notification includes physical injury, adverse effects, improper disclosure of private information, and other potentially harmful occurrences.

For proprietary or classified concerns, contact DOE or your human subjects coordinator.

Protection of Human Research Subjects (CTR-134)   

Protecting Human Subjects in Research (MCP-3619)   

Human Subject Research (PDD-131)   

Federal-wide Assurance   

IRB Members 

DOE Protecting Human Subjects   

DOE Human Subjects Order (443.1B) 

DOE Human Subjects Protection Resource Book   
 
DOE Worker Health-Related Studies and Programs 

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